FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES

Tampon, Menstrual, Unscented

FIRST QUALITY HYGIENIC, INC.

The following data is part of a premarket notification filed by First Quality Hygienic, Inc. with the FDA for Femtex Tampons And Other Private Label Plastic Applicator Tampons; Consumer Packages And Bulk Packages.

Pre-market Notification Details

Device IDK023479
510k NumberK023479
Device Name:FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES
ClassificationTampon, Menstrual, Unscented
Applicant FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE Allendale,  NJ  07401
ContactRobert J Staab
CorrespondentRobert J Staab
FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE Allendale,  NJ  07401
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-17
Decision Date2002-11-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40024291290436 K023479 000
00024291290438 K023479 000
10024291290435 K023479 000

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